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Orange Book product · Generic (ANDA)

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

Generic (ANDA)ANDA 209035TE ABRX STRIDES PHARMA

At a glance

Jun 09, 2017

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 09, 2017

    9 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMANTADINE HYDROCHLORIDE

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 209035

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMANTADINE HYDROCHLORIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.